Table 2 IDMC recommendations from first four meetings

First Meeting (25 February 2009):

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Requested details of adverse event reporting and listings of all individual events by patient identification

Second Meeting (18 June 2009):

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Requested information on children screened for the trial but not enrolled

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Requested the number and quantity of additional fluids (other than boluses) given to all children

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Asked the study teams to make extra effort to ensure that all children attend for neurological examination at 28 days

Third meeting (12 October 2009):

∙

Endorsed the review procedure for SAE proposed, and stressed the importance of blinded review by the ERC

∙

Accepted co-enrollment of children into other studies

∙

Noted planned sub-studies

Fourth meeting (26 January 2010, third interim analysis):

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Observed improvement in attendance for neurological follow up at 28 days

∙

Referred the request by a local IRB for representation on the IDMC to the TSC

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Requested more detailed information on all fluids received in each arm by time from randomization

∙

Agreed with the proposed plan of analysis